DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Low Back Pain Clinical Trial

Official title:

DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05201573
• Other study ID #: CP21001
• Status: Not yet recruiting
• Start date: January 17, 2022
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2022
• Source: Companion Spine, LLC
• Contact: Sherif S Elsherif
• Phone: 202.552.5893
• Email: ssamy[@]mcra.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

Description:

Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol. Data collected at one-time point from subjects with at least 5 years of follow-up data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
• Willing and able to consent to study procedures

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Other:
• Observational
This is an observational study of long term follow up data for patients who previously received the DIAM implant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Companion Spine, LLC	MCRA, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety associated with the use of the investigational implant during long term follow up	The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up.; Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.	5-10 years after implantation
Secondary	Back Pain evaluation	Composite overall success consisting of: Pain/disability (Oswestry) success (=15 pt. improvement relative to baseline) No serious adverse event is classified as "implant-associated", "procedure associated" or "implant-/surgical procedure associated." No additional surgical procedure at the involved level is classified as a failure.	5-10 years after implantation
Secondary	Back Pain evaluation	Change in back pain score compared to baseline	5-10 years after implantation
Secondary	Back Pain evaluation	Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency)	5-10 years after implantation
Secondary	Back Pain evaluation	SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0	5-10 years after implantation